The EU Green Deal's ambition for a toxic-free environment: Filling the gap for science-based policymaking.

Around the world, many ambitious environmental conventions and regulations have been implemented over recent decades. Despite this, the environment is still deteriorating. An increase in the volume and diversity of chemicals is one of the main drivers of this deterioration, of which biodiversity loss is a telling indicator. In response to this situation, in October 2020, a chemicals strategy for sustainability (CSS) was published in the EU. The CSS is the first regional framework aiming to address chemical pollution in a holistic manner. The CSS covers the complete lifecycle of a chemical, including the design of better substances and remediation options, to remove chemicals from the environment. The strategy contains terms, such as a "toxic-free environment," for which no clear definition exists, potentially hampering the implementation of the CSS. In this paper, a definition for a "toxic-free environment" is proposed on the basis of a survey and a discussion held at the 2020 SETAC Europe Annual Meeting. In addition, key issues that are absent from the CSS but are considered to be key for the realization of a toxic-free environment are identified. To achieve the policy goals, it is recommended to align the definition of risk across the different chemical legislations, to establish a platform for open data and data sharing, and to increase the utility and use of novel scientific findings in policymaking, through the development of a strong science to regulation feedback mechanism and vice versa. The paper concludes that environmental scientists have the tools to address the key challenges presented in the CSS. However, an extra step is needed by both policymakers and scientists to develop methods, processes and tools, to increase the robustness and transparency of deliberation processes, and the utility of science. Integr Environ Assess Manag 2021;17:1105-1113. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

On the role of review papers in the face of escalating publication rates - a case study of research on contaminants of emerging concern (CECs).

In the past few decades, there has been a dramatic increase in scientific publications dealing with contaminants of emerging concern (CECs) and the escalating publication rate makes it close to impossible for individual researchers to get an overview of the field. Assuring the relevance and quality of the research conducted in any research field is a crucially important task. The rapidly increasing publication rates imply that review papers will play a progressively more central role to that end. The aim of the present paper is to critically assess whether reviews dealing with contaminants of emerging concern (CECs) are effective vehicles for a healthy dialogue about methodological weaknesses, uncertainties, research gaps and the future direction of the field. We carried out a tiered content-analysis of CEC review papers. Relevant papers were identified through searches in Web of Science (Clarivate), leading to the identification of 6391 original research papers of which 193 are review papers. We find that the majority of CEC reviews are written as if they are comprehensive, even though this clearly is not the case. A minority (~20%) take a critical-analytical approach to the reviewing task and identify weaknesses and research gaps. The following widespread tendencies in CEC research papers are commonly noted as concerning: to equate removal of CECs to 'decreased concentrations in the effluent'; to focus on parent substances and not concern oneself with degradation products; to focus on most commonly studied substances rather than those of most concern; to not deal with the corollary of our inability to detect or assess the risk for all substances, and to give insufficient attention to uncertainties and the unknown. Several critical-analytical reviews are among the highest cited, which suggests that they have the potential to function as effective vehicles for a healthy dialogue on these topics. On the other hand, it would appear that the concerns expressed in these reviews have a limited impact, as the same concerns are repeated over time. This might be due to a tendency among review authors to express their concerns implicitly, instead of clearly spelling them out. Our study suggests that CEC reviews presently fail to provide adequate and reliable guidance regarding the relevance and quality of research in the field. We argue that the overwhelming number of publications in combination with a lack of quality criteria for review papers are reasons to this failure: it is well documented that choices made during the reviewing process have a major impact on the outcome of a review. These choices include: search engine; the criteria used to include or exclude papers; the criteria used to assess the quality of the data generated in the research papers included; the criteria used for the choice of substances/ organisms/ technologies reported on. The lack of transparent procedures makes it very difficult, if not impossible, to assess the quality of the findings presented or to put those findings in context. In this light, it is noteworthy that criteria for a good review paper are rarely spelled out by peer-reviewed journals or included in instructions on scientific writing. The dramatic increase in publications is a challenge for the entire research community, particularly for research fields that are expected to provide policy-relevant data. We argue that only when peer-reviewed journals start specifying quality criteria for review papers, can such papers be relied upon to provide adequate and strategic guidance on the development of CEC research. We anticipate that our findings and conclusions are valid for many other research fields.

More for less: Analysis of the performance of avian acute oral guideline OECD 223 from empirical data.

Since the publication of the Organisation for Economic Co-operation and Development (OECD) avian acute oral guideline, OECD 223, empirical data have become available to compare the performance of OECD 223 with statistical simulations used to validate this guideline and with empirical data for US Environmental Protection Agency Office of Chemical Safety and Pollution Prevention (USEPA OCSPP) guideline OCSPP 850.2100. Empirical studies comprised 244 for Northern bobwhite, of which 73 were dose-response tests and 171 were limit tests. Of the dose-response tests, 26 were conducted to OECD 223 (using 3-4 stages) and 33 to OCSPP 850.2100 (using the single 50-bird design). Data were collected from 5 avian testing laboratories from studies performed between 2006 and 2013. The success with which the LD50 and slope could be determined was 100% and 96% for OECD 223 (mean 26 birds per test) and 100% and 51% for OCSPP 850.2100 (mean 50 birds per test). This was consistent with the statistical simulations. Control mortality across all species and designs amounted to 0.26% (n = 2655) with only single mortalities occurring in any 1 study and <1% for any 1 species. The simulations used to validate the OECD 223 design showed that control mortality up to 1% will have no observable impact on the performance. The distribution of time to death for Northern bobwhite, zebra finch, and canary were obtained from 90, 29, and 17 studies, and mortalities appeared within 3 d for 71%, 95%, and 91% of birds tested, respectively. Integr Environ Assess Manag 2017;13:906-914. © 2017 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances.

A SETAC Pellston Workshop® "Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)" was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review. The workshop additionally considered recent developments in the identification of EDS. Case studies were undertaken on 6 endocrine-active substances (EAS-not necessarily proven EDS, but substances known to interact directly with the endocrine system) that are representative of a range of perturbations of the endocrine system and considered to be data rich in relevant information at multiple biological levels of organization for 1 or more ecologically relevant taxa. The substances selected were 17α-ethinylestradiol, perchlorate, propiconazole, 17ß-trenbolone, tributyltin, and vinclozolin. The 6 case studies were not comprehensive safety evaluations but provided foundations for clarifying key issues and procedures that should be considered when assessing the ecotoxicological hazards and risks of EAS and EDS. The workshop also highlighted areas of scientific uncertainty, and made specific recommendations for research and methods-development to resolve some of the identified issues. The present paper provides broad guidance for scientists in regulatory authorities, industry, and academia on issues likely to arise during the ecotoxicological hazard and risk assessment of EAS and EDS. The primary conclusion of this paper, and of the SETAC Pellston Workshop on which it is based, is that if data on environmental exposure, effects on sensitive species and life-stages, delayed effects, and effects at low concentrations are robust, initiating environmental risk assessment of EDS is scientifically sound and sufficiently reliable and protective of the environment. In the absence of such data, assessment on the basis of hazard is scientifically justified until such time as relevant new information is available. Integr Environ Assess Manag 2017;13:267-279. © 2017 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Ecotoxicological hazard and risk assessment of endocrine active substances.

This collection of papers provides state-of-the-art science on a complex topic that has been challenging for scientists and regulators for a long time. The papers emanated from the Society of Environmental Toxicology and Chemistry (SETAC) Pellston Workshop® Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA). Forty-eight international experts met in early February 2016 to discuss whether the environmental risks posed by endocrine-disrupting substances (EDS) can be reliably assessed. The primary conclusion of the workshop was that if data on environmental exposure, effects on sensitive species and life-stages, delayed effects, and effects at low concentrations are robust, initiating environmental risk assessment of EDS is scientifically sound and reliable. Integr Environ Assess Manag 2017;13:264-266. © 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).